+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

Digital Biopsy - Market Insights, Competitive Landscape, and Market Forecast - 2032

  • PDF Icon

    Report

  • 150 Pages
  • June 2025
  • Region: Global
  • DelveInsight
  • ID: 6107804
Digital Biopsy Market by Technique (Radiofrequency Imaging, Ultrasound, Optical Imaging, X-ray, and Others), Indication (Skin Cancer, Brain Cancer, Breast Cancer, and Others), End-User (Hospitals, Diagnostic Imaging Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the growing incidence of cancer globally and rising shift towards non-invasive diagnostic procedures.

The digital biopsy market is estimated to grow at a CAGR of 16.87% during the forecast period from 2025 to 2032. The demand for digital biopsy is rising globally, driven by the increasing incidence of cancers such as breast cancer, brain cancer, melanoma, squamous cell carcinoma, basal cell carcinoma, and others. A growing preference for non-invasive diagnostic methods, along with ongoing technological advancements in digital biopsy systems, is further supporting this trend. These factors are creating a strong foundation for sustained market growth, positioning the digital biopsy market for steady and robust expansion from 2025 to 2032.

Digital Biopsy Market Dynamics:

According to data from GLOBOCAN (2023), approximately 20 million new cancer cases were reported globally in 2022, with projections indicating a rise to 32.6 million cases by 2045. This steep increase underscores the urgent need for more efficient, accurate, and scalable diagnostic technologies such as digital biopsy solutions.

Skin cancer is among the fastest-growing cancer types globally. As reported by the International Agency for Research on Cancer (IARC, 2022), an estimated 330,000 new melanoma cases were diagnosed worldwide in 2022, with nearly 60,000 deaths. Similarly, the National Institutes of Health (2025) reported that approximately 331,722 individuals were diagnosed with melanoma globally in 2024. The rising incidence of skin cancer is significantly contributing to the demand for digital biopsy technologies, which offer a non-invasive, repeatable, and real-time method for screening and early detection, especially critical for melanoma and other skin cancers.

Breast cancer also remains a major global health challenge. According to the World Health Organization (2024), 2.3 million women were diagnosed with breast cancer in 2022, with 670,000 deaths recorded globally. Digital biopsy solutions help address this challenge by enabling clinicians to non-invasively differentiate between benign and malignant lesions, reduce unnecessary surgical biopsies, and accelerate diagnostic decision-making, ultimately leading to improved patient outcomes.

Furthermore, the growing incidence of brain tumors further highlights the need for advanced diagnostic methods. Data from Brain Tumour Research UK (2024) revealed that over 16,000 people were diagnosed with brain tumors annually in the UK, while the Australian Government (2024) reported about 2,000 new brain cancer cases each year. Digital biopsy technologies provide a transformative approach in such cases by helping to identify tumor type and grade (e.g., glioblastoma versus low-grade gliomas) without the need for physically removing tissue, minimizing patient risk, and supporting more timely interventions.

In addition to rising disease burden, technological innovation and product approvals are also accelerating market growth. For instance, in November 2023, BrainSpec announced that the FDA approved BrainSpec Core™, a cutting-edge non-invasive digital biopsy device designed for the detection of brain tumors. Utilizing advanced imaging technology, BrainSpec Core™ analyzes the concentration of chemicals within the brain to generate a virtual biopsy, all through the use of standard MRI scanners. This innovative approach allows for accurate tumor diagnosis without the need for invasive tissue removal, marking a significant advancement in brain cancer diagnostics.

However, the technical limitations associated with digital biopsy devices and the availability of alternative products, among others, are some of the key constraints that may limit the growth of the digital biopsy market.

Digital Biopsy Market Segment Analysis:

Digital Biopsy Market by Technique (Radiofrequency Imaging, Ultrasound, Optical Imaging, X-ray, and Others), Indication (Skin Cancer, Brain Cancer, Breast Cancer, and Others), End-User (Hospitals, Diagnostic Imaging Centers, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the technique segment of the digital biopsy market, the radiofrequency imaging category is estimated to account for the largest market share in 2024. The growth of this category is primarily driven by the rising global incidence of cancer and the increasing adoption of advanced, non-invasive diagnostic technologies such as radiofrequency imaging and digital biopsy devices.

According to the European Commission (2023), in 2022, approximately 2.74 million new cancer cases were reported in Europe, with around 3.7 million new cases diagnosed annually across the continent. Similarly, the World Health Organization (2023) reported that over 2.3 million people were diagnosed with cancer each year in the South-East Asia Region. This growing cancer burden has significantly increased demand for early detection and minimally invasive diagnostic solutions, fueling the demand for radiofrequency imaging digital biopsy solutions.

One of the most notable benefits of radiofrequency imaging digital biopsy devices is their non-invasive or minimally invasive nature, which significantly enhances their appeal in modern clinical settings. These advanced tools leverage imaging technologies and artificial intelligence (AI) to analyze tissues in real time, thereby reducing or eliminating the need for traditional surgical biopsies.

As a result, they enable faster diagnosis, allow for repeatable assessments for ongoing monitoring, and improve patient comfort by minimizing physical trauma. Additionally, by avoiding tissue excision, these devices help lower the risk of complications such as bleeding, infection, and scarring, making them particularly valuable in primary care and outpatient environments.

Moreover, the market is witnessing technological innovation and regulatory momentum. In January 2024, DermaSensor, Inc. received FDA clearance for DermaSensor, a digital biopsy device designed to detect all three common types of skin cancer, including melanoma, basal cell carcinoma, and squamous cell carcinoma. This marked a significant milestone in expanding access to non-invasive cancer diagnostics at the primary care level.

Thus, the factors mentioned above are likely to boost the market segment and thereby increase the overall market of digital biopsy across the globe.

North America is expected to dominate the overall digital biopsy market:

North America is projected to hold the largest share of the digital biopsy market in 2024, driven by several key factors. This regional dominance is primarily attributed to the rising incidence of cancer, growing adoption of non-invasive diagnostic methods, and a strong focus on technological innovation. The region benefits from a well-established healthcare infrastructure, favorable reimbursement policies, and high awareness among clinicians. Additionally, various product approvals and advancements by key market players are accelerating adoption and solidifying North America's dominant market position.

According to data from the International Agency for Research on Cancer (2025), the number of new cancer cases in the U.S. was 2,380,189 in 2022, with projections indicating a significant rise to 3,380,124 cases by 2045. Among these, leukemia had 63,100 new cases in 2022, expected to increase to 88,600 by 2045. Similarly, data from the Canadian Cancer Society (2024), over 11,300 people were diagnosed with melanoma skin cancer in Canada.

According to the American Cancer Society (2025), an estimated 104,960 new cases of melanoma were expected to be diagnosed in the U.S. in 2025, along with approximately 5.4 million cases of basal and squamous cell skin cancers annually. The same source also reported that 24,820 malignant tumors of the brain or spinal cord (14,040 in males and 10,780 in females) were projected to be diagnosed in 2025.

Additionally, in 2024, approximately 310,720 new cases of invasive breast cancer were reported. This increasing cancer burden is significantly driving demand for advanced digital biopsy solutions for early screening and accurate diagnosis.

Moreover, the market is being fueled by technological advancements and product approvals. For example, in October 2024, VPIX Medical Inc. announced that it had received FDA approval for its digital biopsy system, cCeLL-In vivo. This device works by converting laser scanning signals into digital tissue images through direct contact with the patient's body, enabling accurate, real-time diagnosis of brain cancer.

Collectively, the rising burden of cancer, the shift towards non-invasive diagnostics, and product approvals by key players are propelling the demand for digital biopsy in North America, reinforcing its position as a leading region in the global market.

Digital Biopsy Market Key Players:

Some of the key market players operating in the digital biopsy market include DermaSensor, Inc., SciBase, VITA IMAGING, Inc., MetaOptima Technology Inc., VPIX Medical Inc., Mauna Kea Technologies, Skin Analytics, Trafita Medical System, BRAINSPEC, Imaging Biometrics, LLC, Optovibronex, LLC, FUJIFILM Holdings Corporation, Canon Inc., VivaScope GmbH, and others.

Recent Developmental Activities in the Digital Biopsy Market:

  • In May 2025, SciBase Holding AB announced that over 300,000 Nevisense melanoma detection tests had been used worldwide. Nevisense is a digital biopsy device that helps dermatologists assess suspicious moles and evaluate a patient's melanoma risk, enabling more accurate and personalized care at the point of diagnosis.  

Key takeaways from the digital biopsy market report study

  • Market size analysis for current digital biopsy market size (2024), and market forecast for 8 years (2025 to 2032)
  • Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
  • Key companies dominating the digital biopsy market.
  • Various opportunities available for the other competitors in the digital biopsy market space.
  • What are the top-performing segments in 2024? How these segments will perform in 2032?
  • Which are the top-performing regions and countries in the current digital biopsy market scenario?
  • Which are the regions and countries where companies should have concentrated on opportunities for digital biopsy market growth in the future?

Target audience who can benefit from this digital biopsy market report study

  • Digital biopsy product providers
  • Research organizations and consulting companies
  • Digital biopsy-related organizations, associations, forums, and other alliances
  • Government and corporate offices
  • Start-up companies, venture capitalists, and private equity firms
  • Distributors and traders dealing in digital biopsy
  • Various end-users who want to know more about the digital biopsy market and the latest technological developments in the digital biopsy market.

Frequently Asked Questions for the Digital Biopsy Market:

1. What is digital biopsy?

  • Digital biopsy is a non-invasive diagnostic technique that uses advanced imaging technologies, artificial intelligence (AI), and data analysis to examine tissues or organs at the cellular or subcellular level without the need for physically extracting a tissue sample, as in a traditional biopsy.

2. What is the market for digital biopsy?

  • The digital biopsy market is estimated to grow at a CAGR of 16.87% during the forecast period from 2025 to 2032.

3. What are the drivers for the digital biopsy market?

  • The demand for digital biopsy is rising globally, driven by the increasing incidence of cancers such as breast cancer, brain cancer, melanoma, squamous cell carcinoma, basal cell carcinoma, and others. A growing preference for non-invasive diagnostic methods, along with ongoing technological advancements in digital biopsy systems, is further supporting this trend. These factors are creating a strong foundation for sustained market growth, positioning the digital biopsy market for steady and robust expansion from 2025 to 2032.

4. Who are the key players operating in the digital biopsy market?

  • Some of the key market players operating in the digital biopsy market include DermaSensor, Inc., SciBase, VITA IMAGING, Inc., MetaOptima Technology Inc., VPIX Medical Inc., Mauna Kea Technologies, Skin Analytics, Trafita Medical System, BRAINSPEC, Imaging Biometrics, LLC, Optovibronex, LLC, FUJIFILM Holdings Corporation, Canon Inc., VivaScope GmbH, and others.

5. Which region has the highest share in the digital biopsy market?

  • North America is projected to hold the largest share of the digital biopsy market in 2024, driven by several key factors. This regional dominance is primarily attributed to the rising incidence of cancer, growing adoption of non-invasive diagnostic methods, and a strong focus on technological innovation. The region benefits from a well-established healthcare infrastructure, favorable reimbursement policies, and high awareness among clinicians. Additionally, various product approvals and advancements by key market players are accelerating adoption and solidifying North America's dominant market position.

This product will be delivered within 2 business days.

Table of Contents

1. Digital Biopsy Market Report Introduction
1.1. Scope of the Study
1.2. Market Segmentation
1.3. Market Assumption
2. Digital Biopsy Market Executive Summary
2.1. Market at Glance
3. Competitive Landscape
4. Regulatory Analysis
4.1. The United States
4.2. Europe
4.3. Japan
4.4. China
5. Digital Biopsy Market Key Factors Analysis
5.1. Digital Biopsy Market Drivers
5.1.1. The growing incidence of cancer globally
5.1.2. Rising shift towards non-invasive diagnostic procedures
5.1.3. Technological advancements in product development in the domain of digital biopsy systems
5.2. Digital Biopsy Market Restraints and Challenges
5.2.1. Technical limitations associated with digital biopsy devices
5.2.2. Availability of alternative products
5.3. Digital Biopsy Market Opportunity
5.3.1. Integration of advanced technologies in digital biopsy systems, such as artificial intelligence (AI), predictive analytics, among others
6. Digital Biopsy Market Porter's Five Forces Analysis
6.1. Bargaining Power of Suppliers
6.2. Bargaining Power of Consumers
6.3. Threat of New Entrants
6.4. Threat of Substitutes
6.5. Competitive Rivalry
7. Digital Biopsy Market Assessment
7.1. By Technique
7.1.1. Radiofrequency Imaging
7.1.2. Ultrasound
7.1.3. Optical Imaging
7.1.4. X-ray
7.1.5. Others
7.2. By Indication
7.2.1. Skin Cancer
7.2.2. Breast Cancer
7.2.3. Brain Cancer
7.2.4. Others
7.3. By End-User
7.3.1. Hospitals
7.3.2. Diagnostic Imaging Centers
7.3.3. Others
7.4. By Geography
7.4.1. North America
7.4.1.1. United States Digital Biopsy Market Size in USD million (2022-2032)
7.4.1.2. Canada Digital Biopsy Market Size in USD million (2022-2032)
7.4.1.3. Mexico Digital Biopsy Market Size in USD million (2022-2032)
7.4.2. Europe
7.4.2.1. France Digital Biopsy Market Size in USD million (2022-2032)
7.4.2.2. Germany Digital Biopsy Market Size in USD million (2022-2032)
7.4.2.3. United Kingdom Digital Biopsy Market Size in USD million (2022-2032)
7.4.2.4. Italy Digital Biopsy Market Size in USD million (2022-2032)
7.4.2.5. Spain Digital Biopsy Market Size in USD million (2022-2032)
7.4.2.6. Rest of Europe Digital Biopsy Market Size in USD million (2022-2032)
7.4.3. Asia-Pacific
7.4.3.1. China Digital Biopsy Market Size in USD million (2022-2032)
7.4.3.2. Japan Digital Biopsy Market Size in USD million (2022-2032)
7.4.3.3. India Digital Biopsy Market Size in USD million (2022-2032)
7.4.3.4. Australia Digital Biopsy Market Size in USD million (2022-2032)
7.4.3.5. South Korea Digital Biopsy Market Size in USD million (2022-2032)
7.4.3.6. Rest of Asia-Pacific Digital Biopsy Market Size in USD million (2022-2032)
7.4.4. Rest of the World (RoW)
7.4.4.1. Middle East Digital Biopsy Market Size in USD million (2022-2032)
7.4.4.2. Africa Digital Biopsy Market Size in USD million (2022-2032)
7.4.4.3. South America Digital Biopsy Market Size In USD Million (2022-2032)
8. Digital Biopsy Market Company and Product Profiles
8.1. DermaSensor, Inc.
8.1.1. Company Overview
8.1.2. Company Snapshot
8.1.3. Financial Overview
8.1.4. Product Listing
8.1.5. Entropy
8.2. SciBase
8.2.1. Company Overview
8.2.2. Company Snapshot
8.2.3. Financial Overview
8.2.4. Product Listing
8.2.5. Entropy
8.3. VITA IMAGING, Inc.
8.3.1. Company Overview
8.3.2. Company Snapshot
8.3.3. Financial Overview
8.3.4. Product Listing
8.3.5. Entropy
8.4. MetaOptima Technology Inc.
8.4.1. Company Overview
8.4.2. Company Snapshot
8.4.3. Financial Overview
8.4.4. Product Listing
8.4.5. Entropy
8.5. VPIX Medical Inc.
8.5.1. Company Overview
8.5.2. Company Snapshot
8.5.3. Financial Overview
8.5.4. Product Listing
8.5.5. Entropy
8.6. Mauna Kea Technologies
8.6.1. Company Overview
8.6.2. Company Snapshot
8.6.3. Financial Overview
8.6.4. Product Listing
8.6.5. Entropy
8.7. Skin Analytics
8.7.1. Company Overview
8.7.2. Company Snapshot
8.7.3. Financial Overview
8.7.4. Product Listing
8.7.5. Entropy
8.8. Trafita Medical System
8.8.1. Company Overview
8.8.2. Company Snapshot
8.8.3. Financial Overview
8.8.4. Product Listing
8.8.5. Entropy
8.9. BRAINSPEC
8.9.1. Company Overview
8.9.2. Company Snapshot
8.9.3. Financial Overview
8.9.4. Product Listing
8.9.5. Entropy
8.10. Imaging Biometrics, LLC
8.10.1. Company Overview
8.10.2. Company Snapshot
8.10.3. Financial Overview
8.10.4. Product Listing
8.10.5. Entropy
8.11. Optovibronex, LLC
8.11.1. Company Overview
8.11.2. Company Snapshot
8.11.3. Financial Overview
8.11.4. Product Listing
8.11.5. Entropy
8.12. FUJIFILM Holdings Corporation
8.12.1. Company Overview
8.12.2. Company Snapshot
8.12.3. Financial Overview
8.12.4. Product Listing
8.12.5. Entropy
8.13. Canon Inc.
8.13.1. Company Overview
8.13.2. Company Snapshot
8.13.3. Financial Overview
8.13.4. Product Listing
8.13.5. Entropy
8.14. VivaScope GmbH
8.14.1. Company Overview
8.14.2. Company Snapshot
8.14.3. Financial Overview
8.14.4. Product Listing
8.14.5. Entropy
9. KOL Views
10. Project Approach
11. About the Publisher
12. Disclaimer
List of Tables
Table 1: Competitive Analysis
Table 2: Digital Biopsy Market in Global (2022-2032)
Table 3: Digital Biopsy Market in Global by Technique (2022-2032)
Table 4: Digital Biopsy Market in Global by Indication (2022-2032)
Table 5: Digital Biopsy Market in Global by End-User (2022-2032)
Table 6: Digital Biopsy Market in Global by Geography (2022-2032)
Table 7: Digital Biopsy Market in North America (2022-2032)
Table 8: Digital Biopsy Market in the United States (2022-2032)
Table 9: Digital Biopsy Market in Canada (2022-2032)
Table 10: Digital Biopsy Market in Mexico (2022-2032)
Table 11: Digital Biopsy Market in Europe (2022-2032)
Table 12: Digital Biopsy Market in France (2022-2032)
Table 13: Digital Biopsy Market in Germany (2022-2032)
Table 14: Digital Biopsy Market in United Kingdom (2022-2032)
Table 15: Digital Biopsy Market in Italy (2022-2032)
Table 16: Digital Biopsy Market in Spain (2022-2032)
Table 17: Digital Biopsy Market in the Rest of Europe (2022-2032)
Table 18: Digital Biopsy Market in Asia-Pacific (2022-2032)
Table 19: Digital Biopsy Market in China (2022-2032)
Table 20: Digital Biopsy Market in Japan (2022-2032)
Table 21: Digital Biopsy Market in India (2022-2032)
Table 22: Digital Biopsy Market in Australia (2022-2032)
Table 23: Digital Biopsy Market in South Korea (2022-2032)
Table 24: Digital Biopsy Market in Rest of Asia-Pacific (2022-2032)
Table 25: Digital Biopsy Market in the Rest of the World (2022-2032)
Table 26: Digital Biopsy Market in the Middle East (2022-2032)
Table 27: Digital Biopsy Market in Africa (2022-2032)
Table 28: Digital Biopsy Market in South America (2022-2032)
List of Figures
Figure 1: Competitive Analysis
Figure 2: Digital Biopsy Market in Global (2022-2032)
Figure 3: Digital Biopsy Market in Global by Technique (2022-2032)
Figure 4: Digital Biopsy Market in Global by Indication (2022-2032)
Figure 5: Digital Biopsy Market in Global by End-User (2022-2032)
Figure 6: Digital Biopsy Market in Global by Geography (2022-2032)
Figure 7: Digital Biopsy Market in North America (2022-2032)
Figure 8: Digital Biopsy Market in the United States (2022-2032)
Figure 9: Digital Biopsy Market in Canada (2022-2032)
Figure 10: Digital Biopsy Market in Mexico (2022-2032)
Figure 11: Digital Biopsy Market in Europe (2022-2032)
Figure 12: Digital Biopsy Market in France (2022-2032)
Figure 13: Digital Biopsy Market in Germany (2022-2032)
Figure 14: Digital Biopsy Market in United Kingdom (2022-2032)
Figure 15: Digital Biopsy Market in Italy (2022-2032)
Figure 16: Digital Biopsy Market in Spain (2022-2032)
Figure 17: Digital Biopsy Market in the Rest of Europe (2022-2032)
Figure 18: Digital Biopsy Market in Asia-Pacific (2022-2032)
Figure 19: Digital Biopsy Market in China (2022-2032)
Figure 20: Digital Biopsy Market in Japan (2022-2032)
Figure 21: Digital Biopsy Market in India (2022-2032)
Figure 22: Digital Biopsy Market in Australia (2022-2032)
Figure 23: Digital Biopsy Market in South Korea (2022-2032)
Figure 24: Digital Biopsy Market in Rest of Asia-Pacific (2022-2032)
Figure 25: Digital Biopsy Market in the Rest of the World (2022-2032)
Figure 26: Digital Biopsy Market in the Middle East (2022-2032)
Figure 27: Digital Biopsy Market in Africa (2022-2032)
Figure 28: Digital Biopsy Market in South America (2022-2032)
Figure 29: Market Drivers
Figure 30: Market Barriers
Figure 31: Marker Opportunities
Figure 32: PORTER'S Five Force Analysis

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

  • DermaSensor, Inc.
  • SciBase
  • VITA IMAGING, Inc.
  • MetaOptima Technology Inc.
  • VPIX Medical Inc.
  • Mauna Kea Technologies
  • Skin Analytics
  • Trafita Medical System
  • BRAINSPEC
  • Imaging Biometrics, LLC
  • Optovibronex, LLC
  • FUJIFILM Holdings Corporation
  • Canon Inc.
  • VivaScope GmbH